Trials Sponsors Conditions Drugs Pricing

Conditions

Diaphyseal Fracture Proximal Humeral Fracture Proximal Tibia Fractures

Keywords

Medical devicePerformanceSafetyClinical benefitsDiaphysisProximal humerusProximal TibiaFracturePost Market Clinical Follow Up Study

Outcome Measures

Primary Outcomes (1)

Performance: Fracture Healing
Performance will be assessed by analyzing fracture healing radiographically or clinically. Timepoints at which the data will be collected will be summarized through means.
At last consultation visit either at minimum 6 months post-operative by radiographic assessment or, if no x-rays available, by clinical assessment at the follow-up phone call at minimum 1 year postoperative.

Secondary Outcomes (4)

Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
At operative evaluation, immediate post-operative evaluation, last consultation visit at minimum 6 months post-operative and at the follow-up phone call at minimum 1 year postoperative.

Study Arms (1)

Patients implanted with the Zimmer® Plates and Screws System

Patients who already received the Zimmer® Plates and Screws System in the Diaphysis, Proximal Humerus and Proximal Tibia.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Consecutive series of cases implanted with plates and screws belonging to the Zimmer® Plates and Screws System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

You may qualify if:

Patients having received one of the plates belonging to the Zimmer® Plates and Screws System, designed for temporary internal fixation to stabilize fractures during the normal healing process. In this study we will collect data specifically on Zimmer® Plates and Screws System plates belonging to the Diaphysis, Proximal Humerus and Proximal Tibia groups.

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

SC Clinica Ortopedica e Traumatologica II IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

MeSH Terms

Conditions

Shoulder FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesShoulder Injuries

Limitations and Caveats

A limitation to this study is its retrospective design. Due to this, no patients implanted with a Zimmer® Plates and Screws System plate in the proximal humerus could be enrolled in this study.

Results Point of Contact

Title: Andrea Singer
Organization: Zimmer Biomet

Study Officials

Hassan Achakri
Zimmer Biomet
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

57 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

January 31, 2022

Study Start

March 15, 2023

Actual (reported)

PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Patients implanted with the Zimmer® Plates and Screws System

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Patients implanted with the Zimmer® Plates and Screws System

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations